Consulting Wallah › Device Explorer › Dental › Dental power tool system handpiece, pneumatic
Device Explorer · FDA GUDID · GMDN 40958

Dental power tool system handpiece, pneumatic

A hand-held dental device that includes a chuck for attaching a rotary dental endpiece (e.g., drill bits, burs, reamers) intended to be used in dentistry to bore/excavate bones, teeth, and tough tissues. The device incorporates a small turbine motor normally d

US‑registered devices425in commercial distribution
Companies15labelers on GUDID
Single‑use6%of device records
Sterile6%labelled sterile
Prescription68%Rx‑only share
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Share of device records

Henry Schein, Inc.9222%
Microp Technology (Taiwan) Inc.5112%
Handpiece Parts & Repairs, Inc.5112%
Beyes Dental Canada Inc4711%
Mk-Dent Gmbh4110%
Kavo Dental Gmbh317%
Associated Industries China, Inc.266%
Beijing Dongbo Dental Handpiece Co.,Ltd.246%

Top labelers

CompanyDevicesShare
Henry Schein, Inc.9222%
Microp Technology (Taiwan) Inc.5112%
Handpiece Parts & Repairs, Inc.5112%
Beyes Dental Canada Inc4711%
Mk-Dent Gmbh4110%
Kavo Dental Gmbh317%
Associated Industries China, Inc.266%
Beijing Dongbo Dental Handpiece Co.,Ltd.246%
Flight Dental Systems194%
Foshan Wenjian Medical Instrument Co., Ltd.164%
Darby Dental Supply, Llc133%
Ultradent Products, Inc.61%

Company = labeler of record on GUDID. 15 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

wenjianDental Low-speed Turbine HandpieceDental High-speed Turbine HandpieceHigh-speed Turbine Handpieces for Single UseSURGtorque S459 CSURGtorque LUX S459 LMASTERtorque Mini Kids Edition (en)EXPERT LUX Case 680465LRNSMART Case 619460CSMART LUX Case 619460LMASTERtorque LUX M8900 LSMARTtorque Mini S605 CSMARTtorque S609 CSMARTtorque Mini LUX S615 LSMARTtorque S619 CSMARTtorque LUX S619 L

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
EFBHandpiece, Air-Powered, Dental249
EFBHandpiece, air-powered, dental88
EGSHandpiece, Contra- And Right-Angle Attachment, Dental60
EGSHandpiece, contra- and right-angle attachment, dental31
EFBHANDPIECE, AIR-POWERED, DENTAL24
ELCScaler, ultrasonic1

GMDN & GCC registration

  • GMDN code 40958 · non‑implantable
  • Single‑use 6% · sterile 6% · Rx‑only 68% · OTC 10%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

No structured size data on the register.

Use these as the dimensions to specify in a tender line.

How many dental power tool system handpiece, pneumatic products are registered in the US?

425 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dental power tool system handpiece, pneumatic", from 15 companies. The largest labeler is Henry Schein, Inc. with 22% of records.

Which FDA product codes apply?

EFB (Handpiece, Air-Powered, Dental), EFB (Handpiece, air-powered, dental), EGS (Handpiece, Contra- And Right-Angle Attachment, Dental), EGS (Handpiece, contra- and right-angle attachment, dental)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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